Field of the Invention
The present invention pertains generally to a device for surgical correction and prevention of breast ptosis and acts as an internal long term absorbable matrix brassiere. More particularly, the invention constitutes a device, made of available long term absorbable matrices, that repairs or re-enforces the anatomy of the breast and is responsible for its shape and anchorage to the chest wall via the circum-mammary ligament.
Brief Discussion of the Related Art
Brassieres had their origin in the 19th century and were preceded by the corset, which was fabricated in one piece with ribbing as supports, originally made of whalebone then metal, to push the breast up and squeeze the waistline in. The origins of similar articles of fashion dates back 3,000 years to the Minoan civilization, whose Snake Goddess wore a corset like device which pushed the breasts up and together, exposing them in an uncovered central position. The succeeding Mycenaeans continued the tradition, as the breast held special cultural and religious significance to them. These undergarments have always had roots dually in fashion and the more practical supportive health concerns. They have been an expression of female beauty and social hierarchy.
One hundred years ago, Mary Phelps Jacob (after marriage known as Caresse Crosby), obtained a patent from the US patent office for a backless brassiere she made from two handkerchiefs. Legend has it that Mary, who was a 19 year old member of New York City society, had to create an alternative to a corset when planning her ensemble for the debutant ball. She and her maid attached two handkerchiefs together with pink ribbon and a cord. The fashion was such a success that her friends commissioned more made for themselves. Realizing she had invented something useful, Mary went on to submit a patent for a “Backless Brassier”, which was granted in November of 1914. Years later she would sell this intellectual property to Warners Brothers Corset Company, of Bridgeport, Conn.
Plastic Surgery figured prominently in the story of youthful, full, and lifted breast, when the breast implant was introduced in the 1960's. Thomas Cronin and Frank Gerow collaborated with Dow Corning in 1961 to develop the first silicone breast implant. Shortly after, in 1962 the first breast augmentation with a silicone implant was performed. The rest, as they say, is history; over 300,000 breast implant surgeries are performed each year.
The anatomy of the breast and chest has a great deal to do with the shape and perkiness of the breast, something both bras and implants are trying to influence. The breast, an organ consisting of both glandular tissue and fat, is shaped by collagen connective tissue, called fascia that anchors and supports the breast to the underlying chest wall. Sir Astly Cooper, in the 19th century, described the two layers of superficial fascia that surround the breast and anchor it to the chest wall. He described the connective tissue extensions, named after him (Coopers ligaments) which run from this superficial fascia up to the under surface of the skin to anchor the skin to the breast. It has been felt that when Coopers ligaments stretch out, the breasts then sag. However, what has not been appreciated until now is the exact nature of how the superficial fascia attaches to the chest—the circum-mammary ligament. This fascia, like a corral, is called the circum-mammary ligament, which defines the perimeter of the breast. In addition it fuses to the fascia covering the chest wall and anchors it in place. The most defined aspect of this structure is located under the breast, called the infra-mammary fold ligament. The next most developed is the medial, or inner aspect of the corral. This inner portion of the circum-mammary ligament causes the separation between the breasts and is responsible for the cleavage. Laterally, towards the outer portion of the breast, the cir-cum-mammary ligament is not as strong or well defined. It is this portion of the suspensory ligament of the breast that is most responsible for sagging, or ptosis, of the breast. As was previously mentioned, the breast sits upon the chest wall which is its foundation. The foundation has a great deal of impact on the shape and projection of the breast. Most human anatomy is not perfectly geometric or symmetric. Thus there are usually differences in the boney rib cage on the left and right that lead to asymmetry of the breasts. With a person lying on their back, or as anatomist say the supine position, the rib cage is like a flattened cylinder—that is wider than it is tall. Also, as one travels from the center point of the chest, or sternum, towards the outer or lateral aspect, the flat portion of the chest must slope downward. As one moves out from the center and around the chest, it becomes more cylindrical as it turns to the back, which once again is flattened. The portion of the breast located on the downward slope of the lateral chest wall, effects how it is pulled down by gravity in the supine position, or pressed away from the center of the chest in the prone position (like the keel of a boat pushing through water). So it is true that gravity pulls the breast down but this happens because the inherent anatomy (weaker attachment of the circum-mammary ligament to the chest and a sloping chest wall laterally) and its effect in the prone and supine position. A flatter, more rectangular chest supports the breast position more than a more rounded, cylindrical chest which leaves the breast attached to the side of the chest without an underlying foundation. Since the human form is asymmetric, one can have less support from the chest on one side, than on the other, resulting in more sagging, or ptosis, on that side. The larger the breast, the more the stretching force. The presence of breast implants can greatly exacerbate this situation.
Ironically, plastic surgery involving breast implants frequently weakens the body's natural, internal bra—the superficial fascia system and circum-mammary ligament. Even more destructive to the shape of the breast is mastectomy for breast cancer. Despite modern skin and nipple sparing procedures, having been accepted as cutting edge cancer care, most surgeons are insufficiently knowledgeable or skilled to save the circum-mammary ligament, and take full advantage of this minimally invasive approach to mastectomy.
Therefore many woman, with large heavy breast or women who have had breast surgery, end up with weakened supporting structures of the breast and suffer breast sagging. The original breast lift and reduction technique was developed by plastic surgeon Robert J. Wise. It used a “key hole” skin reduction pattern that left an anchor shaped scar on the breast. A technique which followed, by LeJour, omitted the horizontal scar in the infra-mammary fold and is referred to as the “lollipop” scar. In the 1990's a minimal scar technique developed by a French plastic surgeon named Binelli was popularized to correct breast sagging as a primary mastopexy or in conjunction with a breast implant. This approach did not use large skin reductions, as in previous techniques, but limited scars to the peri-areolar border and used internal sutures to shape the breast gland. A plastic surgeon in South America, Goes, was even more innovative and added the use of synthetic permanent mesh fabrics, placed between the skin and breast gland, to shape the breast in a manner consistent with an internal bra. Because these permanent implants were too frequently palpable or resulted in complications related to the mesh (infection, erosion, chronic pain) most American doctors did not adopt these imaginative techniques.
In recent years, tissue grafts were used to treat these problems. In situations where breast implants or mastectomy surgery had broken down the natural support structures of the lateral, inferior or medial boundaries, a cadaver or animal skin graft, known as acellular dermis, was used to repair the stretched out tissues. In 2010, as an alternative to tissue grafts, Novus Scientific introduced the first long term absorbable synthetic matrix for repair and support of weak or damaged body tissues. Since, three other large medical manufacturers have introduced similar products. But still they all have been used as substitutes for tissue grafts (that are two dimensional sheets) like their acellular dermal predicates.
U.S. Pat. No. 6,055,989 to Rehnke deals with the principle of fascial clefts. Fascial clefts are potential anatomic spaces between layers of known fascia in the body which are fused together at anatomic boundaries. Because the fascia is thin and transparent, like Saran wrap, it can be invisible to those not skilled in the art. However, once one is aware of its presence, its effects can be appreciated and used to great surgical advantage. In the region of the breast, knowledge of the superficial and deep fascial relationships is crucial to all surgeries on this organ. The '989 patent teaches the use of blunt, balloon dissection of the fascial cleft below the breast known as the “sub-glandular space.” It was found that the sub-glandular fascial cleft could be opened by balloon dissectors, which would dissect until they reached the peripheral borders of the breast, as defined by the circum-mammary ligament.
The breast is an organ of ectodermal origin, whose cells penetrate the mesoderm and organize into a network of lobular milk producing cells which are connected to the nipple through milk ducts, lined by ductal cells. These breast tissue cells, of ectodermal origin, are surrounded by mesenchymal fat cells, and contained within a dense connective tissue capsule making up what is known as the “corpus mammae”. (The corpus mammae is what must be removed during mastectomy for breast cancer.) The corpus mammae is sandwiched between the two layers of superficial fascia and a surrounding insulating layer of fat. Deep to this sandwich, and just on top of the deep fascia of the pectoralis major is the fascial cleft known as the sub-glandular space. The two layers of superficial fascia, that surround the breast, fuse to each other and the deep fascia in a circle around the breast, defining its boundaries and shaping its form; it is known as the “circum-mammary, or circum-mammary or circumferential mammary ligament” The decusating and intermingling fibers of the superficial fascia and deep fascia fibers are mixed with varying amounts of fat, depending on the percent body fat of the patient and the particular aspect of the circum-mammary ligament. For instance, it is thickest and most defined at the inferior border at the fifth costal interspace, or “infra-mammary fold”. The medial aspect of this lazy circular border is the reason for the cleavage point between the breast, and is well defined but not thick and fatty. The lateral aspect is less well defined but wide, much more elastic than the inferior or medial boundaries, and located just anterior to the anterior axillary line. Superiorly, the circum-mammary ligament is at its thinnest and hardest to appreciate, in comparison to the infra-clavicular region.
US Published Patent Application No. 2008/0300681 to Rigott et al indicates that if a tissue expander device is placed within layers of tissue in the human anatomy and gradually exerts tensile stress on the tissue, it will induce biologic tissue growth in a desired fashion. Furthermore, it teaches the injection of fat, stem cells (and other progenitor cell) growth factors and pharmaceuticals into the tissue layer experiencing tensile stress. It recapitulates the teachings of the Rehnke '989 patent in regards to the fascial cleft anatomy of the breast and its natural boundary, the circumferential mammary ligament. Rigott states that, “it has been found that these defined layers also offer a region for tissue growth as disclosed herein”.
U.S. Published Patent Application No. 2012/0221105 to Altman et al relates to an implantable device for use in tissue and ligament repair. The device is comprised of knitted, slowly absorbable silk fibers with a continuous fiber traversing it. The preferred embodiment involves its use as a sheet of fabric, or mesh, that is used in place of acellular dermal cadaver grafts in the performance of breast reconstructions and all manner of cosmetic breast surgeries and mention that a scaffold can be used, as an internal scaffold to act as a bra to immediately support a geometrically complex implantation site at the time of surgery which would ideally provide the body both time and structure necessary for optimal healing. Simple sheets of two dimensional matrix are used to reinforce various regions of the breast depending on the need of each clinical case. The device, shown as a sheet of fabric, is simply folded over to reinforce regions of the breast borders, such as infra-mammary fold, medial cleavage, or lateral border. Known surgical procedures and maneuvers that have been a part of plastic surgery of the breast for ten years are used with the substitution of the absorbable silk synthetic material for the traditional acellular dermis product.
U.S. Pat. No. 7,998,152 B2 to Frank shows an implantable device made for use in a peri-areolar mastopexy, which allows for a transfer of shaping tensions to the device, as opposed to simply on to the permanent purse string used in per-areolar mastopexy. The device is annular or frusto-conical in configuration and can be constructed of absorbable material or acellular tissue graft. The truncated, cone shaped device may have a series of teeth extending out from the surface that engages the breast gland, and thus holds it in the more desirable projecting state seen in youthful breasts. It is designed to be placed through the peri-areolar incision, under the skin and on the superficial surface of the breast gland. It allows for use of an absorbable peri-areolar suture, that tightens the skin envelop around the areola. The device addresses only the skin envelope relaxation, seen in breast ptosis; it does not address the more important causation of breast sagging, the enlargement and stretching out of the circum-mammary ligament.
Professors Jain Farhadi and Kefah Mokbel have performed a surgical procedure at Guy's Hospital in London, making use of an implantable device developed in 2007, wherein a synthetic bra made of a silicone cup is placed between the skin and the lower pole of the breast; it is anchored to the rib cage with silk straps.